Hatch-Waxman Integrity Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 990 To amend the Federal Food, Drug, and Cosmetic Act and the Securities Exchange Act of 1934 to prevent the inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and with respect to drug innovation, and for other purposes. IN THE HOUSE OF REPRESENTATIVES FEBRUARY 6, 2019 Mr. FLORES introduced the following bill; which was referred to the Com- mittee on Energy and Commerce, and in addition to the Committee on Financial Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend the Federal Food, Drug, and Cosmetic Act and the Securities Exchange Act of 1934 to prevent the inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and with respect to drug innovation, and for other pur- poses. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Hatch-Waxman Integ- 4 rity Act of 2019’’. 5 VerDate Sep 11 2014 02:01 Feb 15, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H990.IH H990 pamtmann on DSKBFK8HB2PROD with BILLS 2 •HR 990 IH SEC. 2. PREVENTING THE INTER PARTES REVIEW PROCESS 1 FOR CHALLENGING PATENTS FROM DIMIN- 2 ISHING COMPETITION IN THE PHARMA- 3 CEUTICAL INDUSTRY AND WITH RESPECT TO 4 DRUG INNOVATION. 5 (a) BRAND NAME DRUGS.—Section 505(b)(2) of the 6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 7 355(b)(2)) is amended— 8 (1) in subparagraph (A)(iv), by striking ‘‘and’’ 9 at the end; 10 (2) in subparagraph (B), by striking the period 11 at the end and inserting ‘‘; and’’; and 12 (3) by adding at the end the following: 13 ‘‘(C) in each certification required under sub- 14 paragraph (A) with respect to a patent, a certifi- 15 cation that— 16 ‘‘(i) neither the applicant nor any party in 17 privity with, related to, or cooperating with the 18 applicant has filed, or will file, a petition to in- 19 stitute inter partes review or post-grant review 20 of that patent under chapter 31 or 32, respec- 21 tively, of title 35, United States Code; and 22 ‘‘(ii) in making the certification required 23 under subparagraph (A), the applicant is not 24 relying in whole or in part on any decision 25 issued by the Patent Trial and Appeal Board in 26 VerDate Sep 11 2014 02:01 Feb 15, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H990.IH H990 pamtmann on DSKBFK8HB2PROD with BILLS 3 •HR 990 IH an inter partes review or post-grant review 1 under chapter 31 or 32, respectively, of title 35, 2 United States Code.’’. 3 (b) GENERIC DRUGS.—Section 505(j)(2)(A) of the 4 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 5 355(j)(2)(A)) is amended— 6 (1) in clause (vii)(IV), by striking ‘‘and’’ at the 7 end; 8 (2) in clause (viii), by striking the period at the 9 end and inserting ‘‘; and’’; 10 (3) by inserting after clause (viii), as amended 11 by paragraph (2), the following: 12 ‘‘(ix) in each certification required under 13 clause (vii) with respect to a patent, a certifi- 14 cation that— 15 ‘‘(I) neither the applicant nor any 16 party in privity with, related to, or cooper- 17 ating with the applicant has filed, or will 18 file, a petition to institute inter partes re- 19 view or post-grant review of that patent 20 under chapter 31 or 32, respectively, of 21 title 35, United States Code; and 22 ‘‘(II) in making the certification re- 23 quired under clause (vii), the applicant is 24 not relying in whole or in part on any deci- 25 VerDate Sep 11 2014 02:01 Feb 15, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H990.IH H990 pamtmann on DSKBFK8HB2PROD with BILLS 4 •HR 990 IH sion issued by the Patent Trial and Appeal 1 Board in an inter partes review or post- 2 grant review under chapter 31 or 32, re- 3 spectively, of title 35, United States 4 Code.’’; and 5 (4) in the flush text following clause (ix), as 6 added by paragraph (3), by striking ‘‘(viii)’’ and in- 7 serting ‘‘(ix)’’. 8 (c) BIOSIMILAR DRUGS; EVALUATION BY THE SEC- 9 RETARY.—Section 351(k) of the Public Health Service Act 10 (42 U.S.C. 262(k)) is amended— 11 (1) in paragraph (2)(A)(iii)— 12 (A) by redesignating subclauses (I) and 13 (II) as items (aa) and (bb), respectively, and 14 adjusting the margins accordingly; 15 (B) in the matter preceding item (aa), as 16 so redesignated, by striking ‘‘An application’’ 17 and inserting the following: 18 ‘‘(I) IN GENERAL.—An application’’; 19 (C) in subclause (I), as so designated— 20 (i) in item (aa), as so redesignated, by 21 striking ‘‘and’’ at the end; 22 (ii) in item (bb), as so redesignated, 23 by striking the period at the end and in- 24 serting ‘‘; and’’; and 25 VerDate Sep 11 2014 02:01 Feb 15, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H990.IH H990 pamtmann on DSKBFK8HB2PROD with BILLS 5 •HR 990 IH (iii) by adding at the end the fol- 1 lowing: 2 ‘‘(cc) shall, with respect to a 3 patent described in subclause 4 (II), include a certification that 5 neither the applicant nor any 6 party in privity with, related to, 7 or cooperating with the applicant 8 has filed, or will file, a petition to 9 institute inter partes review or 10 post-grant review of the patent 11 under chapter 31 or 32, respec- 12 tively, of title 35, United States 13 Code.’’; and 14 (D) by adding at the end the following: 15 ‘‘(II) PATENT DESCRIBED.—A 16 patent is described in this subclause 17 if— 18 ‘‘(aa) the patent covers the 19 reference product or a method 20 for using the reference product; 21 and 22 ‘‘(bb)(AA) the reference 23 product described in item (aa) is 24 VerDate Sep 11 2014 02:01 Feb 15, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H990.IH H990 pamtmann on DSKBFK8HB2PROD with BILLS 6 •HR 990 IH marked under section 287(a) of 1 title 35, United States Code; or 2 ‘‘(BB) there is otherwise 3 public notice regarding the appli- 4 cability of the reference product 5 described in item (aa).’’; and 6 (2) in paragraph (3)— 7 (A) in subparagraph (A)(ii), by striking 8 ‘‘and’’ at the end; 9 (B) in subparagraph (B), by striking the 10 period at the end and inserting ‘‘; and’’; and 11 (C) by adding at the end the following: 12 ‘‘(C) the Secretary determines that the ap- 13 plication fully complies with the requirements 14 under paragraph (2)(A)(iii).’’. 15 SEC. 3. PREVENTING THE MANIPULATIVE AND DECEPTIVE 16 USE OF INTER PARTES REVIEW. 17 Section 10(b) of the Securities Exchange Act of 1934 18 (15 U.S.C. 78j(b)) is amended— 19 (1) by inserting ‘‘(1)’’ after ‘‘(b)’’; and 20 (2) by adding at the end the following: 21 ‘‘(2) For purposes of paragraph (1), a person shall 22 be considered to be using a manipulative or deceptive de- 23 vice if— 24 VerDate Sep 11 2014 02:01 Feb 15, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H990.IH H990 pamtmann on DSKBFK8HB2PROD with BILLS 7 •HR 990 IH ‘‘(A) the person, or an affiliate of the person, 1 files a petition to institute an inter partes review 2 under chapter 31 of title 35, United States Code, 3 with respect to a patent; and 4 ‘‘(B) the person, or an affiliate of the person, 5 during the 180-day period beginning on the date 6 that is 90 days before the date on which the person 7 files the petition described in subparagraph (A), en- 8 gages in a short sale of any publicly traded security 9 of the owner of the patent that is the subject of the 10 petition.’’. 11 Æ VerDate Sep 11 2014 02:01 Feb 15, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H990.IH H990 pamtmann on DSKBFK8HB2PROD with BILLS